Perioperative/Postoperative Complications
Conditions
Brief summary
Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.
Detailed description
Bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. On the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. Pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.
Interventions
OTHERVery low-calorie protein-based diet
Patients will receive a homemade very low-calorie (\ 5 kcal/kg of ideal body weight /day) protein-based formula (milk proteins; 1.2 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
OTHERHypocaloric diet
Patients will receive a commercial balanced enteral formula (\ 20 kcal/kg of ideal body weight /day; protein content, 1.0 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
Sponsors
San Giuseppe Moscati Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation * Availability to long-term post-operative follow-up * Normal kidney function serum creatinine ≤ 1,2 mg/dL and glomerular filtration rate ≥ 90 mL/min * Normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase \< 2 x N) * written informed consent
Exclusion criteria
* age \<18 or \>60 anni * serum creatinine \>1,2 mg/dl * liver failure (Child-Pugh ≥ A) * insuline-dependent diabetes mellitus * atrioventricular block with QT \> 0,44 ms * Cardiac arrythmias * Moderate-severe cardiac failure * Hypokaliemia * Chronic diarrhoea or vomitus * 12-month previous cardio-vascular disease * pregnancy and/or lactation * current/previous neoplastic disease * psychiatric disorders * know gastro-intestinal diseases * other controindications to enteral nutrition * moderate-severe hypo-albuminemia (\<3.0 mg/dL) * 6-month previous diet-induced weight loss * intragastric balloon * unavailability to planned measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery duration | End of surgery, an expected average of 3.5 hours | from skin incision to wound closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite intra-operative complications | End of surgery, an expected average of 3.5 hours | Hemorrhage, organ perforation or laceration, conversion to open surgery, stapler dysfunction |
| Composite post-operative complications | 30 days | Any-type hemorrhage, any-type infections, wound dehiscence, anastomotic leak, organ dysfunction |
| Intra-operative bleeding | End of surgery, an expected average of 3.5 hours | — |
| Difficult intubation | Before surgery | — |
| Time to remove surgical drain | Hospital stay, an avarage of 9 days | — |
| Total drain fluid production | Hospital stay, an avarage of 9 days | — |
| Change of multiple biochemical parameters | End of dietary intervention, 28 days | blood lipids, variables of glucose metabolism and growth-hormone axis |
| Change in liver fibrosis | End of dietary intervention, 28 days | — |
| Change in liver volume | End of dietary intervention, 28 days | — |
| Change in visceral fat | End of dietary intervention, 28 days | — |
| Change of multiple body composition parameters | End of dietary intervention, 28 days | — |
| Change in handgrip strength | End of dietary intervention, 28 days | — |
| Change of multiple cardiac morpho-functional parameters | End of dietary intervention, 28 days | — |
| Length of hospital stay | Hospital stay, an avarage of 9 days | — |
| Composite complications of enteral feeding | End of dietary intervention, 28 days | tube dysfunction, nausea, vomiting, diarrhea |
| Change of multiple anthropometric parameters | End of dietary intervention, 28 days | body mass index, body weight, waist and hip circumferences |
Countries
Italy
Contacts
Primary ContactGiuseppe Castaldo, MD
Outcome results
None listed